Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1305818
Name of medicinal product: AMMILY 2 MG / 0,03 MG
Active substances:
Dienogest+Ethinylestradiol
Estonian, English, Latin
ATC code: G03AA16
Dosage form: film-coated tablet
Route of administration: oral use
Strengh: 2mg+0,03mg
Amount in package: 21TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: - Oral contraception. - Treatment of moderate acne after failure of suitable topical therapies or oral antibiotic treatment in women who elect to use an oral contraceptive. The decision to prescribe [invented name] should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with [invented name] compares with other CHCs (see sections 4.3 and 4.4).
Safety features: Yes
Summary of product characteristics (SPC):  (last updated April 12, 2023)
Package information leaflet (PIL): EST  (last updated April 12, 2023)
Labelling:  (last updated November 3, 2021)
Last imported to Estonia: May 26, 2023
Marketing authorization holder: Orivas UAB 
Marketing authorization number: 617409 
Marketing authorization issued on: February 6, 2009 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
90  01.04.2023     Yes  Z30-Z30    No  4 years - 17 years  sünnitamisele meditsiinilise vastunäidustuse korral 
100  01.04.2023     Yes  Z30-Z30    No  until 4 years  sünnitamisele meditsiinilise vastunäidustuse korral 
100  01.04.2023     Yes      No  until 4 years   
75  01.04.2023     Yes  Z30-Z30    No     sünnitamisele meditsiinilise vastunäidustuse korral 
90  01.04.2023     Yes  Z30-Z30    No     sünnitamisele meditsiinilise vastunäidustuse korral 
50  01.04.2023     Yes      No      
90  01.04.2023     Yes  Z30-Z30    No  from 63 years  sünnitamisele meditsiinilise vastunäidustuse korral 
90  01.04.2023     Yes  Z30-Z30    No     sünnitamisele meditsiinilise vastunäidustuse korral 
Reference price: 5,67 EUR 
Under reference price: Yes 
Reference price of daily dose: 0,27 EUR 
Description Additional condition
Ämmaemandal on õigus välja kirjutada
Perearsti õel on õigus välja kirjutada Välja arvatud esmane retsept
Entry/Changing date: April 12, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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